MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number	FG13160-0615-1S
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the solitaire x experienced resistance at the phenom 21 microcatheter hub during preparation.They tried several times slowly, but the device could not enter the catheter.The solitaire was damaged in the phenom catheter hub, and the hub of the catheter was cracked. the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Additional information was received.It was clarified that the distal part of solitaire was damaged.For the cause of the event it was reported that, "we guess it's a phenom problem.".
Additional Manufacturer Narrative
H3: the solitaire x revascularization device and phenom 21 catheter were returned for analysis.The solitaire x revascularization device was returned within its introducer sheath.The solitaire x pusher was found bent at 12.5cm, 9.5cm, 8.0cm, and 1.0cm from the pusher distal end.The solitaire x stent was found still attached to the pusher.The solitaire x stent non-working (tear drop) length struts were found bent.The solitaire x stent working length struts were found to be in good condition.No damages were found with the phenom 21 catheter hub.The phenom 21 catheter body was found kinked at 61.0cm from the proximal end of the catheter hub.No damages were found the phenom 21 catheter distal tip.The solitaire x revascularization device was pushed out from within its introducer sheath with resistance.The phenom 21 catheter was flushed, water exited from the distal tip.An in-house mandrel was inserted into the phenom 21 catheter; however, resistance was encountered 10.0cm from the proximal end of the catheter hub.The phenom 21 catheter was dissected at 10.0cm and the inner liner was found damaged.Based on the device analysis and reported information, the customer¿s ¿stent kink/damaged¿ and ¿resistance at hub¿ reports were confirmed.Damage to the solitaire x revascularization device (pusher/stent bent) can occur if advanced against resistance.In this event, the damage found with the phenom 21 catheter inner liner contributed to the reported resistance.However, the cause of the catheter inner liner damage could not be determined.Regarding the customer¿s ¿hub cracked¿ report, the issue could not be confirmed as no damages were found with the phenom 21 catheter hub.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CATHERA
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18909431
• Report Number: 2029214-2024-00444
• Device Sequence Number: 7042792
• Product Code: KRA
• UDI-Device Identifier: 00763000399696
• UDI-Public: 00763000399696
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2026
• Device Model Number: FG13160-0615-1S
• Device Catalogue Number: FG13160-0615-1S
• Device Lot Number: 226412338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown